The Centers for Medicare and Medicaid Services (CMS) has issued an interim final rule on mandatory novel coronavirus (COVID-19) vaccinations for health care workers in facilities that receive Medicaid and/or Medicare monies.  You can read the CMS notice of its interim final rule on mandatory COVID-19 vaccination for health care workers in facilities that receive Medicaid and/or Medicare funding below, including notice of CMS holding a free Webinar on the topic.

Biden-Harris Administration Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Workers

National requirement protects patients at nearly 76,000 providers and covers more than 17 million health care workers

The Biden-Harris Administration is requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. The emergency regulation issued by the Centers for Medicare & Medicaid Services (CMS) today protects those fighting this virus on the front lines while also delivering assurances to individuals and their families that they will be protected when seeking care.

“Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly evolving challenges we’re seeing,” said CMS Administrator Chiquita Brooks-LaSure. “Today’s action addresses the risk of unvaccinated health care staff to patient safety and provides stability and uniformity across the nation’s health care system to strengthen the health of people and the providers who care for them.”

The prevalence of COVID-19, in particular the Delta variant, within health care settings increases the risk of unvaccinated staff contracting the virus and transmitting the virus to patients. When health care staff cannot work because of illness or exposure to COVID-19, the strain on the health care system becomes more severe and further limits patient access to safe and essential care. These requirements will apply to approximately 76,000 providers and cover over 17 million health care workers across the country. The regulation will create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of those delivering care.

Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.

CMS accelerated outreach and assistance efforts encouraging individuals working in health care to get vaccinated following the Administration’s announcement that it would expand the requirement for staff vaccination beyond nursing homes to include additional providers and suppliers. Since the Administration’s announcement, nursing home staff vaccination rates have increased by approximately nine percentage points – from 62 to 71 percent. This increase is encouraging, and this regulation will help to ensure even greater improvement in the vaccination rate among health care workers.

A recent White House report describes the evidence that vaccine requirements work. An analysis of health care systems, educational institutions, public-sector agencies, and private businesses shows that organizations with vaccination requirements have seen their vaccination rates increase by more than 20 percentage points and have routinely seen their share of fully vaccinated workers rise above 90%.

States and individual health systems have historically addressed vaccination requirements for diseases such as influenza and hepatitis B. Today, more than 2,500 hospitals, or 40 percent of all U.S. hospitals, have announced COVID vaccination requirements for their workforce. They span all 50 states, the District of Columbia, and Puerto Rico. The report also found that vaccination requirements have not led to widespread resignations in the health care workforce and that the requirements are an essential tool to protect patients and health care personnel.

CMS will ensure compliance with these requirements through established survey and enforcement processes.  If a provider or supplier does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur. CMS’s goal is to bring health care providers into compliance.  However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients.

The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long Term Care facilities, Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services), Community Mental Health Centers, Home Infusion Therapy suppliers, Rural Health Clinics/Federally Qualified Health Centers, and End-Stage Renal Disease Facilities.

CMS is taking necessary action to establish critical safeguards for the health of all people, their families, and the providers who care for them. CMS knows that everyone working in health care wants to do what is best to keep their patients safe. Yet, unvaccinated staff pose both a direct and indirect threat to the very patients that they serve. Vaccines are a crucial scientific tool in preserving and restoring efficient operations across the nation’s health care system while protecting individuals. This new requirement presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s health care system, and ensure safety for anyone seeking care.

To view the interim final rule with comment period, visit: https://www.federalregister.gov/public-inspection/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination

To view a list of frequently asked questions, visit: www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.docx

CMS just released an Interim Final Rule With Comment Period (IFC-6 https://www.cms.gov/newsroom/press-releases/biden-harris-administration-issues-emergency-regulation-requiring-covid-19-vaccination-health-care) requiring COVID-19 vaccination of staff within all Medicare and Medicaid-certified facilities.  Please join John Blum, CMS’s Principal Deputy Administrator and Dr. Lee Fleisher, Chief Medical Officer and Director of the Center for Clinical Standards and Quality in a discussion of this important rule.

When:   Thursday, November 4, 2021 2:00 – 3:00 PM ET

Who should attend: Leaders and administrators of Medicare and Medicaid Certified Facilities as well as representatives of those who work in such facilities.

RSVP: https://cms.zoomgov.com/webinar/register/WN_7IlEgLznTIm3sqAsv3nHZw

Please RSVP by Thursday, November 4, 2021 at 12:00 PM ET.

After registering, you will receive a confirmation email containing information about joining the webinar.

Questions: please submit questions in advance, with the Subject heading “IFC-6 Stakeholder Call Question” to Partnership@cms.hhs.gov.  On the call, we will answer as many of the questions received by noon as possible  We'll also post a subsequent FAQ document.

Web links:

Press Release: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-issues-emergency-regulation-requiring-covid-19-vaccination-health-care

To view a list of frequently asked questions, visit:

www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.docx

External FAQs are also posted to CMS Current Emergencies Page under ‘Clinical & Technical Guidance for all health care providers’ https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page

Interim Final Rule with Comment Period in Federal Register:

https://www.federalregister.gov/public-inspection/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination or https://public-inspection.federalregister.gov/2021-23831.pdf